Pharmaceutical Technology

APRIL 14, 2023

The US Food and Drug Administration (FDA) has rejected Eli Lilly’s biologic licence application (BLA) for the ulcerative colitis (UC) drug mirikizumab over manufacturing concerns. The regulator has issued a complete response letter. No concerns related to the clinical data package, safety or the medicine label.

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Manufacturing Drugs Hormones Packaging 130

Pharma in Brief

AUGUST 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. Manufacturing Controls. Food and Drug Regulations , C.R.C., Medical Devices Regulations , SOR/98-282. Risk Management Plan (RMP).

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Regulation Drugs Manufacturing Production 98

Drug Patent Watch

FEBRUARY 19, 2025

From inspecting manufacturing facilities to testing finished products, QA teams work tirelessly to guarantee that every pill, tablet, or capsule that reaches the market is safe and effective. But today, I want to shine a spotlight on the often-overlooked heroes of the generic drug industry: Quality Assurance (QA) professionals.

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Generic Drugs Drugs Contamination Manufacturing 92

XTalks

MAY 13, 2022

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. Container closure systems are highly regulated by health agencies. They provide specific guidance on packaging requirements for closed closure integrity (CCI) and general integrity testing.

Packaging 98

Packaging Packaging Containment Production 98

Outsourcing Pharma

NOVEMBER 10, 2021

According to the market intelligence firm, automation appeals to drug packaging and manufacturing firms, thanks to their productivity-boosting potential.

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Packaging Packaging Pharma Packaging Manufacturing 69

pharmaphorum

JUNE 10, 2021

Pharmaceutical Manufacturing & Packaging Congress (PHARMAP 2021) will be held on the 28th – 29th of June, 2021 at the BGS online platform. Pharmaceutical Manufacturing & Packaging Congress provides the networking platform for the decision-makers from the pharmaceutical industry.

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Packaging Packaging Manufacturing Pharma Packaging 52

XTalks

MAY 3, 2024

Challenges and Need for Vigilance: Despite explicit cooking instructions on labels, the persistence of Salmonella -related illnesses underscores the necessity for strict regulations. Approximately one in every 25 chicken packages at grocery stores is contaminated with Salmonella.

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Regulation Production Contamination Packaging 103

XTalks

OCTOBER 7, 2022

As awareness grows around the world about the problem of food waste, one culprit is being scrutinized: best before dates on food packaging. While food and beverage manufacturers have used the labels for decades to estimate peak freshness, consumers are confused about date codes, often causing more food waste than necessary.

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Packaging Packaging Manufacturing Production 97

Pharmaceutical Technology

APRIL 21, 2023

While the FDA sent Lilly a complete response letter detailing issues pertaining to the proposed manufacturing of mirikizumab, the regulator raised no concerns about the clinical data package or label for the medicine. However, that will depend on how quickly Lilly can address the regulator’s manufacturing concerns.

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Manufacturing Sales Packaging Packaging 130

Pharma Packaging Solutions

NOVEMBER 4, 2024

In the complex world of pharmaceutical packaging, selecting the right blister packaging supplier is a critical decision that can significantly impact product presentation, protection, and compliance. At Tjoapack, we are a leading provider of blister packaging solutions designed to meet the unique needs of the pharmaceutical industry.

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Contract Packaging Packaging Packaging Compliance 52

XTalks

MARCH 23, 2022

Since consumers are more health-conscious than ever, some food manufacturers are pulling out all the stops to convince people to purchase highly processed and unhealthy products with misleading food labeling. . Respondents cited packaging as the top area brands should focus on if they want to increase purchase intent.

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Manufacturing Production Branding Packaging 119

Pharma Packaging Solutions

NOVEMBER 8, 2024

Medical device packaging plays a key role in ensuring the safety, efficacy, and integrity of medical devices from the point of manufacture to the end-user. At Tjoapack, we are a premier provider of top-tier medical device packaging services. The packaging must adhere to guidelines set by authorities such as the FDA and EU GMP.

Packaging 52

Packaging Packaging Pharma Packaging Compliance 52

XTalks

NOVEMBER 23, 2021

Canadian pharma and biotech contract development and manufacturing organization (CDMO) Biovectra has announced plans for building one of the first state-of-the-art mRNA vaccine and biomanufacturing facilities in Canada. Additional production would be performed at other facilities for final packaging. million, respectively.

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Manufacturing Vaccination Vaccine Drugs 98

Pharma Packaging Solutions

AUGUST 2, 2022

If you have ever taken any kind of medication, be it prescription or over the counter (and you almost certainly have), then you’re probably familiar with blister packaging. Blister packaging is extremely common in the pharmaceutical industry, thanks to its many benefits. Another benefit of blister packaging is convenience.

Packaging 52

Packaging Packaging Pharma Packaging Regulation 52

XTalks

SEPTEMBER 24, 2020

In terms of the potential harms of food additives and packaging, synthetic chemicals that affect hormones have additive or synergistic effects. Related: FDA Issues First Injunction of its Product Safety Rule. An increasing number of studies suggest some food additives can interfere with a child’s hormones, growth, and development.

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Regulation Hormones Containment Packaging 94

Camargo

NOVEMBER 15, 2021

FDA Publishes ICH Guidelines on Continuous Manufacturing. The FDA recently published the ICH’s Harmonised Guideline Q13, titled “ Continuous Manufacturing of Drug Substances and Drug Products.” Batch steps include filter drying, milling, and packaging.

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Development Manufacturing Production Packaging 187

Camargo

OCTOBER 20, 2021

The regulatory strategy for developing such products needs to be well-designed and should factor in both adaptability and the manufacturing process to minimize overall program risk. However, not every combination product can be classified so easily, and the OCP must follow certain work-flows and regulations to reach a decision.

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Production Regulation Drugs Development 206

XTalks

JUNE 20, 2024

This rule would mandate front-of-package nutrition labeling, which would display key nutrient information on the front of the packaging, in addition to the existing nutrition label on the back. The team discusses which design would be most effective and wonders whether this rule would promote healthier choices.

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Packaging Packaging Protein Manufacturing 59

Pharmaceutical Technology

MARCH 10, 2023

The list also includes manufacturers and suppliers of biological safety cabinets, clean benches, nanotechnology enclosures, drying chambers, vacuum pumps, filters, remote blowers and exhausters, loading and unloading systems as well as controlling and monitoring systems.

Manufacturing 147

Manufacturing Production Containment Antibody 147

Outsourcing Pharma

NOVEMBER 10, 2021

Wasdell, a UK-based packaging and manufacturing provider in the UK, has opened a quality control laboratory in Dundalk to analyze products for its pharmaceutical clientele.

Packaging 52

Packaging Packaging Manufacturing Production 52

Camargo

MAY 2, 2021

Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers. Remember, only those questions listed in the package will be discussed during the INTERACT meeting.

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Gene Therapy Gene Packaging Packaging 155

Pharmaceutical Technology

NOVEMBER 21, 2022

Other contributing factors include the decreasing number of post-market studies and difficulties in primary research and manufacturing. A lower number of clinical trials and regulatory filings were other important influences behind the decision.

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Marketing Sales Manufacturing Drugs 173

Roots Analysis

AUGUST 26, 2024

In today’s global landscape, sustainability has emerged as a pivotal concern across various sectors including the pharmaceutical packaging industry. What is Sustainable Packaging / Green Packaging? The following figure presents the raw materials used by the sustainable packaging companies.

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Packaging Packaging Production Manufacturing 40

pharmaphorum

AUGUST 12, 2022

Embracing Continuous Manufacturing. Continuous manufacturing could be the solution. Unlike batch manufacturing, where drug production is segmented into a series of slow-moving steps, continuous manufacturing relies on a fully integrated process that runs uninterrupted from beginning to end.

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Manufacturing Production Drugs Regulation 59

pharmaphorum

JUNE 18, 2021

Teasing out complex relationships within data lies at the heart of any digital health intervention, but finding the algorithms to do so reliably – and making sure they will be acceptable to regulators – can be a challenge. Sheena Macpherson. The algorithms used in healthcare are becoming more complex as well.

Production 98

Production Regulation Manufacturing Packaging 98

XTalks

JANUARY 17, 2023

The US Food and Drug Administration (FDA) has added sesame to its list of major allergens, making it easier for people with sesame allergies to safely consume packaged food without fear of an allergic reaction. Beginning this year, all food and dietary supplement manufacturers must clearly list sesame as an ingredient on product labels.

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Allergies Packaging Packaging Containment 98

Pharmaceutical Technology

FEBRUARY 3, 2023

CAR T based therapies manufactured with lentiviral vectors are also on the rise, points out Clive Glover, PhD, General Manager, Pall Corporation. Rather, he believes adaptation to suspension-based systems will be an important evolution in AAV manufacturing. Two-Plasmid Packaging System for Recombinant Adeno-Associated Virus.

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Genomics Genome Medicine Gene Therapy 244

FDA Law Blog

MARCH 6, 2022

Mullen — On February 23, 2022, FDA published in the Federal Register a proposed rule that would replace the Quality System Regulation (QSR), at 21 C.F.R. Part 820, with a newly named Quality Management System Regulation (QMSR). ISO 13485, while largely duplicative to the QSR, is not a perfect fit with other existing FDA regulations.

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Regulation Compliance Manufacturing Packaging 52

pharmaphorum

NOVEMBER 24, 2022

Now, this service-centred model is delivering advantages in the pharmaceutical industry, with costly manufacturing facilities and processes becoming widely available on an on-demand basis. µm per cubic metre – with ISO 9 representing the least stringent measures, while still being significantly cleaner than typical manufacturing facilities.

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Manufacturing Pharma Packaging Production Packaging 98

Camargo

JANUARY 12, 2022

INTERACT meeting discussions may focus on topics such as the design of IND-enabling toxicity studies, complex manufacturing technologies or processes, and the development of innovative devices to be used with drug or biologic products. Receipt of Background Package. Response Time. calendar days). At the time of the meeting request.

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Production Gene Therapy Packaging Packaging 169

XTalks

JUNE 18, 2024

This rule would mandate front-of-package nutrition labeling , which would display key nutrient information on the front of the packaging, in addition to the existing nutrition label on the back. The idea of front-of-package nutrition labeling is not new since many countries already use this system.

Packaging 40

Packaging Packaging Production Branding 40

XTalks

SEPTEMBER 17, 2020

Related: FDA Announces Slow Phase-Out of Certain PFAS Chemicals Used in Food Packaging. FDA Chief Counsel Stacy Amin said in a statement , “Manufacturing foods in violation of the Produce Safety Rule and Current Good Manufacturing Practice regulations places consumers’ health at risk.

Production 98

Production Contamination Cosmetics Bacteria 98

XTalks

AUGUST 25, 2023

In the US, the primary agency responsible for regulating allergen labeling on food products is the US Food and Drug Administration (FDA). These certifications are often sought by food manufacturers to assure consumers about the safety of their products for those with food allergies, intolerances and special dietary requirements.

Allergies 98

Allergies Manufacturing Contamination Production 98

XTalks

JULY 26, 2024

In today’s rapidly evolving food industry, enterprise resource planning (ERP) systems for food manufacturers are essential. The Importance of ERP Systems for Food Manufacturers ERP systems are crucial for the food and beverage industry. .” These features make Wherefour an essential tool for food manufacturers.

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Compliance Manufacturing Production Packaging 52

FDA Law Blog

JUNE 12, 2023

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee.

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Regulation Production Cosmetics Sales 45

Pharmaceutical Technology

NOVEMBER 21, 2022

Other contributing factors include the decreasing number of post-market studies and difficulties in primary research and manufacturing. A lower number of clinical trials and regulatory filings were other important influences behind the decision.

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Marketing Sales Manufacturing Drugs 130

XTalks

APRIL 14, 2022

Laura has more than 30 years of experience implementing food safety and quality control programs for packaging, processing, retail operations and food service. Laura has worked with global manufacturers and retailers in the implementation of their workplace and food safety programs.

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Manufacturing Regulation Packaging Packaging 98